Individual donor assessment in the United States: Impact on deferral and infectious disease marker rates.

BACKGROUND

The deferral period for men who have sex with men (MSM) in the US decreased over time from indefinite deferral to 12 to 3 months. In 2023, the US Food and Drug Administration permitted individual donor assessment (IDA), shifting from categorical exclusions to risk behavior-based screening.

METHODS

Trends in HIV risk-based behavior deferrals in a large US collector over similar periods with indefinite MSM, 12-month, and 3-month deferrals versus IDA were analyzed. Rates of confirmed HIV, hepatitis B virus (HBV), and syphilis testing during corresponding pre- and post-IDA periods are reported.

RESULTS

Among males, a significant decrease in HIV risk-based behavior deferrals occurred from indefinite deferral (0.150%) to 12-month (0.114%) to 3-month (0.085%) periods, to IDA (0.067%). For females, MSM contact deferrals significantly decreased from 12-month deferral periods (0.015-0.033%) to 3-month deferral periods (0.007%); post-IDA, rates significantly increased to 0.049%. IDA increased overall deferrals from 0.04% to 0.06% (p < 0.01) compared to the 3-month deferral period. Higher deferrals were seen in males (adjusted odds ratio [aOR] = 1.45 [95% CI = 1.24-1.69]), first-time versus active donors (aOR  = 2.54 [2.12-3.03]), and at ages 19-22 (aOR = 2.73 [2.12-3.52]) compared to 30- and 39-year-olds. IDA implementation did not increase the rates of confirmed HIV, HBV, or active syphilis; however, rates of RPR-negative confirmed syphilis reactivity rose significantly post-IDA.

CONCLUSION

Transition from indefinite MSM deferral to 12 and then 3 months significantly decreased deferral rates. Rates rose in female but not male donors with IDA. IDA implementation did not result in higher rates of confirmed HIV, HBV, or active syphilis. An increase in remote/treated syphilis may be confounded by broader epidemiological trends rather than IDA.